Senior Regulatory Affairs Lead — Submissions & Strategy

Cardinal Health, Inc.; Wyoming; Vor Ort; USD 125.000 - 179.000; Vollzeit

Benefits dieser Stelle

Medical, dental and vision coverage

Paid time off

401k savings plan

Health savings account (HSA)

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Zusammenfassung

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to lead eCTD authoring and regulatory submissions for US and international Health Authorities.

You will drive regulatory strategy for drug development and ensure compliance with NDA/ANDA/MAA requirements throughout product lifecycles. The role requires strong technical writing, risk management, and cross-functional collaboration with manufacturing, QA, and external partners.

Qualifikationen

• 7+ years regulatory affairs hands-on experience in the pharmaceutical (drug and/or biologic) industry required, including management and authorship of eCTD filings for INDs, NDAs, ANDAs, MAAs, and DMFs, regulatory strategy development, risk management, and change control participation.
• Bachelor's degree or equivalent experience in scientific or regulatory field preferred; advanced degree desirable.
• Documented direct interface with Health Authorities via multiple modes (face-to-face, T-con, and emails).
• Excellent knowledge of regulatory and cGMP requirements, including 21 CFR Part 11, Part 210, Part 211, Part 212, Part 314, and other relevant 21 CFR parts and regulatory guidance documents as applied to a sterile injectable drug and oral capsule manufacturing environment.
• Prior work experience with European drug applications (NA, MRP, DP, CP) strongly preferred.
• Knowledge of regulatory requirements as they apply to radiopharmaceuticals preferred; familiarity with nuclear product development, injectable drug products desirable.
• Excellent verbal and written communication skills, including authoring technical documents, authoring correspondence with regulators, and developing and delivering effective presentations.
• Proficient with Microsoft Office software (word processor, spreadsheet, presentation, calendar etc) and able to use software for managing drug applications.
• Diplomacy and negotiation skills, as well as the confidence to take unpopular decisions.
• Ability to work both independently and as a member of a team, smoothly transitioning between the two.
• Occasional travel – 10% or less
• Regulatory Affairs Certification preferred

Aufgaben

• Authorship and/or review and oversight of creation of eCTDs for drug submission to US and outside-US Health Authorities
• Support regulatory strategy for drug development
• Ensure compliance with conditions of approval of NDAs, ANDAs, MAAs and NDSs
• Oversee and perform risk management reviews through products' life cycles and participate in change management internal processes, such as engineering and documentation change control and cross-functional project meetings. This includes identifying optimal scientific and technical paths and regulatory filing routes (e.g. PAS, CBE, or AR in US).
• Provide guidance regarding regulatory requirements for manufacturing sites, encompassing Cardinal Health facilities, contract manufacturing organizations (CMOs), and contract laboratories
• Managing communication with regulatory agencies, such as managing on site/remote meetings, participating in regulatory inspections, and representing the company as required
• Providing regulatory affairs input into program/project teams as required. Participate in and represent RA in cross-functional teams and with manufacturing and testing vendor meetings, as assigned.

Kenntnisse

Regulatory affairs

eCTD filings

Regulatory strategy

Risk management

Change control

Regulatory inspections

Regulatory writing

Regulatory communications

Microsoft Office

Presentation skills

Negotiation

Teamwork

Travel 10%

Ausbildung

Bachelor's degree

Advanced degree desirable

Tools

Jobbeschreibung

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to lead eCTD authoring and regulatory submissions for US and international Health Authorities.

You will drive regulatory strategy for drug development and ensure compliance with NDA/ANDA/MAA requirements throughout product lifecycles. The role requires strong technical writing, risk management, and cross-functional collaboration with manufacturing, QA, and external partners.